# K090778: Mta Protective Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Xylos Corporation
- Decided: Apr 28, 2009 after 36 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K921895 (1992). 53 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081882: Modification to Xylos Surgical Mesh, Xylos Corporation (2008) Summary page 1.
- K072190: Ortho-Wrap Bioresorbable Sheet, Mast Biosurgery (2008) Summary page 1.
- K083823: Securian Tissue Reinforcement Matrix, Xylos Corporation (2009) Summary page 2.

## Most influential descendants
- K100313: Hydrofix Surgical Sheet (2011), 0 descendants of its own
- K100984: Xylos Vessel Guard (2010), 0 descendants of its own

## Indications for use
The MTA Protective Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures. MTA Protective Sheet is intended for one-time use.

Source page: https://510kreport.com/device/K090778
Methodology: https://510kreport.com/methodology